POWDERED VINYL EXAM GLOVES, WHITE

{0}------------------------------------------------ # Kos1104 JUN 1 0 2003 ## 510(k) SUMMARY | Submitted For: | GLORMED INTERNAIONAL, INC. | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | TUCKER & ASSOCIATES<br>Official Correspondent for COPIOUMED<br>JANNA P. TUCKER, President-CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone:<br>775-342-2612<br>Fax:<br>775-342-2613<br>E-Mail:<br>Tuckerjan@aol.com | | Date of Submission: | 2 April 2003 | | Device Name: | POWDERED VINYL EXAM GLOVES,<br>WHITE<br>Class I Device, 80LYZ | | Proprietary Name: | (Multiple Private Labels) | | Labels/Labeling: | This device will be marketed to healthcare professionals at<br>Dentist and Doctor Offices, Laboratories, Clinics and<br>Hospitals through its distributors for the intended use. | | Intended Use: | A patient examination glove is a disposable device intended<br>for medical purposes that is worn on the examiner's hand<br>or finger to prevent contamination between patient and<br>examiner. | | Substantial Equivalence: | Both in its intended use and/or physical<br>characteristics, this device is equivalent to devices<br>currently marketed by U.S. companies. Except for U.S.P.<br>powder, it is the exact same glove manufactured in<br>approved 510(k) KO21353. | EXHIBIT K Page 49 of 50 {1}------------------------------------------------ ## KO31104 510k) Summary page 2. Test Results (Means and/or Successful Results: This device has met or exceeded the following standards and/or tests: ASTM D 5250-00E4 ASTM D 5151-99 ASTM D 6124-01 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315) Conclusion: Except for the U.S.P. powder, this device is the same glove as approved in K021353. EXHIBIT K Page 50 of 50 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is in black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 0 2003 Glormed International, Incorporated C/O Ms. Janna P. tucker Tucker & Associates 198 Avenue de la D' emerald Sparks, Nevada 89434-9550 Re: K031104 Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 2, 2003 Received: April 30, 2003 Dear Ms. Tucker: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Ms. Tucker Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Susan Reusse Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### INDICATIONS FOR USE #### GLORMED INTERNATIONAL, INC. APPLICANT: KO31104 ### 510(k) NUMBER: #### POWDERED VINYL EXAM GLOVES, DEVICE NAME: WHITE A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Olin S. him. (Opti (Optional Format 1-2-96) (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number: K031104 EXHIBIT B Page 2 of 50